During a simple laparoscopic cholecystectomy performed by an experienced surgeon, instruments are switched through the trocars (body cavity surgical access ports) approximately ten to fifteen times. For more complex laparoscopic cholecystectomies, instruments may need to be switched greater than 50 times. More complex minimally invasive surgeries (e.g. laparoscopic hemicolectomies, laparoscopic adrenalectomies, etc.), or more challenging patient characteristics can necessitate even more instrument switching, sometimes hundreds of times per case.
Examples of patient characteristics that may necessitate increased instrument switching include, but are not limited to: presence of “adhesions” (internal scar tissue) from inflammatory processes or previous operations, aberrant anatomy or variations in normal anatomy, weight/patient body habitus (large Body Mass Index (BMI)), and/or complicating disease masses/structures. Given an accurate estimation of 3 to 30 seconds of time per instrument switch, instrument switching therefore accounts for unnecessarily increased operative times. After multiple instrument switches, instrument switching accounts for excess minutes to hours of operative time, depending on case complexity or overall operative time.
Currently, during Minimally Invasive Surgery (MIS), multiple incisions are made in the abdomen, pelvis, thorax or extremity joint spaces, with a “trocar” placed in each incision to serve as a portal for instrument entry into the body cavity. The trocars also serve as one-way valves, allowing instruments to be placed into and removed from body cavities, while not allowing CO2 (used to insufflate the body cavity) to escape during instrument switching or removal. Typically multiple MIS instruments and a laparoscopic camera are required. Frequent instrument switching is almost universally required during MIS, and comprises a significant proportion of MIS case time. Every time an instrument is switched for another, the currently used instrument is removed from the body cavity (usually under direct visualization of the camera) and set down. The electrocautery cable is disconnected from the instrument and reconnected to the next desired instrument. This step requires two hands, either requiring an assistant, or requiring the surgeon to let go of other instruments in order to change the electrocautery cable.
Once the new desired instrument is connected to the electrocautery cable, said instrument is replaced through the trocar into the body cavity to be used. Although this series of actions only takes several seconds to accomplish, the action is required tens to hundreds of times per laparoscopic surgery. The redundancy of motion contributes significantly to increased surgical time and loss of economy of motion, and often requires the surgeon to change visual focus, also increasing surgical time, and compromising safety. Increased surgical time translates directly into increased healthcare costs for surgery centers and hospitals. It also increases patient exposure to: volatile anesthetic agents, non-ergonomic surgical body positioning (with concomitant neurologic risk), hypothermia, excess tissue stress from insufflation and instrument manipulation, and surgical team fatigue during long cases. The excess movement of instruments into and out of body cavities not only increases time, but also the risk of iatrogenic injury (accidental, surgeon-caused injury, e.g. perforation or electrocautery burn) to internal organs and structures. Iatrogenic injury during surgery is another source of excess healthcare costs, both for costly surgical repairs of damaged structures, and for lawsuits associated with such injuries.
Excess time is wasted on instrument switching, resulting in longer operative times, and unnecessary patient safety risks. Examples of wasted time include when: the operation requires a multitude of instrument switches; the electrocautery cord needs to be switched between instruments; the physician needs to adjust grip on other instruments, or switch hands, during switching maneuvers; the physician must take focus away from internal structures, so they need to change the focus of their eyes to perform instrument switches (and re-focusing takes time); the physician needs to “follow” the previous instrument out with the laparoscopic camera, and “follow” the new instrument back in with the camera to perform the switch safely, therefore the physician must reorient themselves with respect to the structures/organs being manipulated when the camera returns its focus to the surgical site (sometimes taking minutes, especially if other tissues or structures fall into the view of the camera and need to be held out of the way repetitively); getting blood/fluid on the camera while moving it around to “follow” instruments, necessitating more time spent cleaning the camera (which often needs to be removed to be cleaned); and, instruments accidentally drop off the sterile field, so time/efficiency/money is wasted on getting new instruments, or sterilizing the previous one. Increased operative time results in decreased efficiency for hospitals and Operating Rooms (ORs).
Further examples of safety being sacrificed as a result of instrument change-out include when: the surgeon does not “follow” instruments in/out of body cavities with the camera, increasing risk of iatrogenic injury to internal structures, such as bowel/other organ perforation; the surgeon has to change visual focus, or shift attention rapidly (again risk of perforation, sheering injury, traction injury, etc.); the surgeon becomes fatigued from increased operative times; extraneous movement inside body cavities increases the likelihood of accidental injury/perforation/thermal injury; extraneous movement inside body cavities causes excess tissue trauma, especially at the trocar sites which are often re-angled multiple times during instrument switching; thermal injury to skin occurs from removing previously used electrocautery instruments out of body and setting somewhere else on the patient; increased operative times results in increased exposure to potentially hazardous surgical environmental conditions (e.g. volatile anesthetics; non-ergonomic body positioning, with increased risks of ischemia (especially to extremities), nerve compression, and muscle necrosis with increased time; operating room conditions, especially hypothermia; and insufflation of body cavities with CO2: excess/prolonged exposure increases the risk of tissue ischemia from increased pressure in abdomen—vasculopaths and pregnant women (gravid uterus) are particularly at risk).
All factors that increase the risk of iatrogenic/accidental injury to the patient place hospitals, hospital systems, surgery centers, and physicians at increased risk of litigation, and are socially, economically, and legally hazardous. Unnecessary injuries to patients are associated with multiple problems for patients and patient families, including loss of life or function, excess pain and suffering, and economic and psychosocial distress if family members die or are unable to work. It is also associated with multiple problems for hospitals and physicians, such as lawsuits, increased malpractice rates, and the economic and resources-based burdens of further procedures to repair iatrogenic injuries, longer hospital stays, and more clinic (follow-up) visits to address the injuries.
Several multi-function laparoscopic devices have been disclosed. However, these instruments are either crude, overly complicated for the surgeon to use, or do not allow for flexibility as to which instruments are used. There are a few points in particular that illustrate problems with prior disclosures. First, many are designed specifically for robots as opposed to surgical hands. Second, many have multiple exit points for the instruments which make it difficult for the surgeon to manage as well as fit in tight spaces within the body. Third, many limit the device to set instruments as opposed to providing the surgeon flexibility on which instruments to use. Fourth, they do not allow advancement or retraction of these instruments into and out of the body with selection of each instrument. Fifth, they do not allow automated changing of instruments mid-procedure, without removing the instruments from the body.
A device is needed that provides surgeons comfort and flexibility to use any laparoscopic instrument she or he desires while not compromising safety for the patient.
While certain novel features of this invention shown and described below are pointed out in the claims, the invention is not intended to be limited to the details specified herein, since a person of ordinary skill in the relevant art will understand that various omissions, modifications, substitutions and changes in the forms and details of the invention illustrated, and in its operation, may be made without departing in any way from the spirit of the present invention. No feature of the invention is critical or essential unless it is expressly stated as being “critical” or “essential.”